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1、BRITISH STANDARD BS EN ISO 9703-3:1999 Anaesthetic and respiratory care alarm signals Part 3: Guidance on application of alarms The European Standard EN ISO 9703-3:1998 has the status of a British Standard ICS 11.040.10 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006,
2、Uncontrolled Copy, (c) BSI BS EN ISO 9703-3:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 1999 BSI 06-1999 ISBN 0 580 30854 5 National
3、 foreword This British Standard is the English language version of EN ISO 9703-3:1998. It is identical with ISO 9703-3:1998. Whereas this standard refers to the alarm signal characteristics given in ISO 9703-1 and ISO 9703-2, it is also suitable for use with the slightly different characteristics gi
4、ven in BS EN 455. The UK participation in its preparation was entrusted to Technical Committee CH/16, Medical alarms and signals, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or
5、 proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CE
6、N and CENELEC standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards
7、 Catalogue under the section entitled ”International Standards Correspondence Index“, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for t
8、heir correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 6 and a
9、 back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53
10、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 9703-3:1999 BSI 06-1999i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 9703-31 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy
11、: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9703-3 November 1998 ICS 11.040.00 Descriptors: See ISO document English version Anaesthesia and respiratory care alarm signals Part 3: Guidance on a
12、pplication of alarms (ISO 9703-3:1998) Signaux dalarme pour lanesthsie et les soins respiratoires Partie 3: Lignes directrices relatives lapplication des alarmes (ISO 9703-3:1998) Alarmsignale fr Ansthesie und Beatmung Teil 3: Leitlinien fr die Anwendung von Alarmen (ISO 9703-3:1998) This European S
13、tandard was approved by CEN on 10 October 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concern
14、ing such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own la
15、nguage and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden
16、, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Mem
17、bers. Ref. No. EN ISO 9703-3:1998 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9703-3:1998 BSI 06-1999 2 Foreword The text of the International Standard ISO 9703-3:1998 has been prepared by Technical Committee ISO/TC 121 “Anaesth
18、etic and respiratory equipment” in collaboration with Technical Committee CEN/TC 259 “Medical alarms and signals”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the la
19、test by May 1999, and conflicting national standards shall be withdrawn at the latest by May 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For rel
20、ationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, De
21、nmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. The text of the International Standard ISO 9703-3:1998 was approved by CEN as a European Standard without any modification. Licensed Copy: s
22、heffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9703-3:1998 ii BSI 06-1999 Contents Page Forewordiii 1Scope1 2Normative references1 3Definition
23、s1 4Alarm signal characteristics1 5Allocation of alarm priorities1 6Alarm limits and settings3 7Alarm silencing, suspension and inhibition4 8Nonlatched alarms4 9Latched alarms4 10Disabling and inhibiting a monitoring function4 11Interface to a remote alarm circuit4 12Avoidance of confusion between s
24、imilar devices5 13Information to be provided by the manufacturer of the medical device5 Annex A (informative) Bibliography6 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU directives6 Figure 1 Severity and urgency of events2 Table
25、1 Allocation of alarm priorities3 Table ZA.1 Correspondence between this European Standard and EU Directives6 Descriptors: Medical equipment, anaesthetic equipment, artificial breathing apparatus, signals, alarm signals, use, rules (instructions). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
26、15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9703-3:1998 BSI 06-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out
27、 through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO col
28、laborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval
29、by at least 75 % of the member bodies casting a vote. International Standard ISO 9703-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. ISO 9703 consists of the following parts, under the general title
30、Anaesthesia and respiratory care alarm signals: Part 1: Visual alarm signals; Part 2: Auditory alarm signals; Part 3: Guidance on application of alarms. Annex A of this part of ISO 9703 is for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrol
31、led Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9703-3:1998 BSI 06-19991 1 Scope This part of ISO 9703 provides guidelines for the application of alarms in equipment intended for use in anaesthesia and respi
32、ratory care. Particular device standards take precedence over this part of ISO 9703. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 9703. At the time of publication, the editions indicated were valid.
33、 All standards are subject to revision, and parties to agreements based on this part of ISO 9703 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
34、ISO 9703-1:1992, Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals. ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals Part 2: Auditory alarm signals. 3 Definitions For the purposes of this part of ISO 9703, the definitions in ISO 9703-1 and ISO 9703-2 and the
35、following definitions apply. 3.1 activated state of a system in which it is capable of performing its intrinsic function 3.2 default alarm settings alarm settings intrinsic to the system, which are preset by the manufacturer, a user, or an operator and which the system itself sets, without further i
36、ntervention, when the alarm system is activated 3.3 disable inactivate an alarm function 3.4 inhibition suppression, until revoked intentionally, of alarm signals 3.5 latched alarm alarm signal for which the visual and auditory components do not stop when the conditions necessary for activation no l
37、onger exist, when limits are restored or when the abnormal patient condition no longer exists 3.6 nonlatched alarm alarm signal for which the visual and/or auditory components cease when the conditions necessary for activation no longer exist 3.7 reset cause the alarm function to revert to its initi
38、al detection state 3.8 silence, verb mute, verb cause the cessation and resetting of an auditory alarm by a deliberate action 3.9 suspension suppression, until revoked automatically, of alarm signals 4 Alarm signal characteristics The visual and auditory attributes of alarms should comply with ISO 9
39、703-1 and ISO 9703-2. 5 Allocation of alarm priorities 5.1 Principle The provision of alarms should never be used as a substitute for good design of anaesthesia and respiratory care devices. ISO 9703-1 and ISO 9703-2 specify the characteristics of auditory and visual alarm signals of high-, medium-
40、and low-priority alarm signals, but do not specify which priority is allocated to a particular alarm on a particular device. To allocate a priority to a particular alarm, it is necessary to evaluate the risk to the patient of the event that the alarm indicates. The term “risk” is usually associated
41、with the potential harm resulting from the event (level of severity) and the likelihood of the occurrence of the event (frequency). The concept of “risk” for alarm priority allocation should be modified by replacing the concept of “frequency” by “level of urgency”. (See ISO 14971 and EN 1441 for gui
42、dance on risk analysis of medical devices.) Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9703-3:1998 2 BSI 06-1999 An event develops over time, either incrementally or suddenly, the latter sometimes being so sudden as to allow litt
43、le or no time for even the most competent operator to take action to avoid potentially hazardous consequences to the patient. IEC 60601-1 requires that the medical device be provided with automatic means to detect and identify sudden, severe events. Some potentially hazardous conditions develop over
44、 a period of time sufficient to allow for manual remedial actions, and the purpose of the alarm is to attract the operators attention to the event and to indicate the speed of response required. 5.2 Factors to be considered 5.2.1 Level of urgency The level of urgency of the event should be categoriz
45、ed into the following. a) Immediate, i.e. having the potential for the event to develop within a period of time not usually sufficient for manual corrective action. b) Prompt, i.e. having the potential for the event to develop within a period of time usually sufficient for manual corrective action.
46、c) Delayed, i.e. having the potential for the event to develop within an unspecified time greater than that given under “prompt” in 5.2.1 b). 5.2.2 Level of severity The level of severity of the event should be categorized into the following, which can also be expressed in a more generic fashion by
47、the corresponding level of physiological threat (as given in parentheses). a) Severe, i.e. death or irreversible injury (severe physiological threat). b) Moderate, i.e. reversible injury (moderate physiological threat). c) Minor, i.e. discomfort or minor injury (minor physiological threat). 5.3 Deri
48、vation and allocation of alarm priorities The allocation of priority to a particular alarm on a particular device should be based on the potential for the development of injury derived from the combination of the factors given in 5.2, as illustrated in Figure 1. From this it can be seen that some ev
49、ents develop immediately at a stated level of severity, whereas others undergo delayed development. Each of the nine fields in Figure 1 represents an alarm priority as given in Table 1, and the allocation of priority should be made in accordance with Table 1. Figure 1 Severity and urgency of events Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:08:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 9703-3:1998 BSI 06-19993 Table 1 Allocation of alarm priorities 5.4 Information signals Information signals are used t